ISO 22870:2016
Point-of-care testing (POCT) — Requirements for quality and competence
ISO 22870:2016 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters.
Patient self-testing in a home or community setting is excluded, but elements of this document can be applicable.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
4.1 Organization and management
4.2 Quality management system
4.3 Document control
4.4 Service agreements
4.5 Examination by referral laboratories
4.6 External services and supplies
4.7 Advisory services
4.8 Resolution of complaints
4.9 Identification and control of nonconformities
4.10 Corrective action
4.11 Preventive action
4.12 Continual improvement
4.13 Quality and technical records
4.14 Internal audits
4.15 Management review
5 Technical requirements
5.1 Personnel
5.2 Accommodation and environmental conditions
5.3 Equipment
5.4 Pre-examination procedures
5.5 Examination procedures
5.6 Assuring the quality of examination procedures
5.7 Post-examination procedure
5.8 Reporting of results
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
4.1 Organization and management
4.2 Quality management system
4.3 Document control
4.4 Service agreements
4.5 Examination by referral laboratories
4.6 External services and supplies
4.7 Advisory services
4.8 Resolution of complaints
4.9 Identification and control of nonconformities
4.10 Corrective action
4.11 Preventive action
4.12 Continual improvement
4.13 Quality and technical records
4.14 Internal audits
4.15 Management review
5 Technical requirements
5.1 Personnel
5.2 Accommodation and environmental conditions
5.3 Equipment
5.4 Pre-examination procedures
5.5 Examination procedures
5.6 Assuring the quality of examination procedures
5.7 Post-examination procedure
5.8 Reporting of results
Bibliography